Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus

Systemic Lupus Erythematosus Clinical Trial

— ESSTIM  

Official title:

Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364908
• Other study ID #: 2013_65
• Secondary ID: 2014-A00735-42
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with a systemic lupus with ACR criteria (at least 4 criterias)

• patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

• patients who refuse to sign the informed consent

• patients who are under guardianship

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• therapeutic education
This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Locations

Country	Name	City	State
France	CH Hôpital Duchenne	Boulogne sur Mer
France	CH Douai	Douai
France	CH Dunkerque	Dunkerque
France	CH du Dr Schaffner	Lens
France	CHRU, Hôpital Huriez	Lille
France	Victor Provo Hospital	Roubaix
France	Valenciennes hospital	Valenciennes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Région Nord-Pas de Calais, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.		baseline, at 12 months
Secondary	hydroxychloroquinémie	Monitoring of blood levels of hydroxychloroquinémie	between 6 months at 12 months
Secondary	number of non- adherent patients	Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;	at 12 months
Secondary	quality of life scale Coping	scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item	baseline, at 12 months